SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Today, members
of the COVID R&D Alliance AbbVie, Inc. (NYSE: ABBV), Amgen Inc.
(NASDAQ: AMGN), and Takeda Pharmaceutical Co. Ltd. (NYSE: TAK)
announced the first patients enrolled in the I-SPY COVID Trial
(Investigation of Serial Studies to Predict Your COVID Therapeutic
Response with Biomarker Integration and Adaptive Learning) clinical
trial. The I-SPY COVID Trial will evaluate the efficacy of
cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist,
Otezla® (apremilast), a PDE4 inhibitor, and
Firazyr® (icatibant injection), a bradykinin B2 receptor
antagonist in severely ill, hospitalized COVID-19 patients who
require high-flow oxygen.
The I-SPY COVID Trial utilizes Quantum Leap Healthcare
Collaborative's adaptive platform trial design, which is intended
to increase trial efficiency by minimizing the number of
participants and time required to evaluate potential
treatments.
"Collaborative research efforts leveraging adaptive platform
trials enable faster and more complete learning about what works
for patients, and they are especially critical for addressing
urgent public health threats like COVID-19," said
Dr. Mark McClellan, director of the Robert J.
Margolis, Center for Health Policy at Duke
University and former commissioner of the U.S. FDA and
administrator of the Centers for Medicare and Medicaid Services.
"Platform trials bring down the cost and increase the ease of
executing well-powered, high quality studies, especially when
multiple, potential therapies need to be evaluated quickly. The
I-SPY COVID Trial is expanding a timely and effective platform
trial strategy to evaluate promising treatments while maintaining
an appropriate level of safety and statistical rigor necessary for
regulatory evaluation."
The study is a collaboration between members of the COVID
R&D Alliance, Quantum Leap, and the U.S. Food and Drug
Administration (FDA). AbbVie, Amgen, and Takeda are members of the
COVID R&D Alliance (COVID R&D), a group of more than 20 of
the world's leading biopharmaceutical and life science companies
working to speed the development of potential therapies, novel
antibodies, and anti-viral therapies for COVID-19 and its related
symptoms.
"Sick patients in hospitals cannot wait; options are urgently
needed. I'm proud to partner with AbbVie and Amgen and the dozens
of other companies who have joined the COVID R&D Alliance, to
initiate critical platform trials like I-SPY COVID," remarked
Andy Plump, President of R&D at
Takeda Pharmaceuticals and co-founder of the COVID R&D
Alliance. "The world learned of COVID-19 only six months ago, and
the speed at which the scientific community has joined forces to
address the critically high unmet need is inspiring. Together,
experts across our companies and industry can accelerate trials
with promising, well-understood therapies that upon investigation,
may show efficacy in this devastating disease."
The therapies under investigation were selected based on their
potential to impact the immune system response of COVID-19 patients
who need respiratory support. Approximately 10-15 percent of
patients afflicted by COVID-19 develop acute respiratory distress
syndrome (ARDS), and up to 60 percent of those patients admitted to
an ICU require ventilation for an average of two weeks. It is
estimated that half of those patients will not survive. Based on
the respective mechanisms of action, Otezla® may
suppress inflammation resulting from an immune response,
Firazyr® may ameliorate bradykinin-driven pulmonary
edema, and cenicriviroc acts by blocking monocytes trafficking to
tissues, features that may help to reduce or mitigate the severity
of ARDS response in severely ill COVID-19 patients.
Dr. Laura Esserman, co-founder of
Quantum Leap Healthcare Collaborative and lead investigator of the
I-SPY Trials stated, "The level of cooperation among pharma
companies in response to the pandemic is unprecedented. The COVID
R&D Alliance stepped forward to streamline the process of
identifying safe, scalable and potentially effective agents and
joined with the I-SPY consortium to propel our efforts forward at
record speed. We are excited to open the trial and work to reduce
the devastating effects of the virus in severely ill COVID
patients, and to do it now, when we need it most."
I-SPY COVID is one of several platform studies being pursued by
members of COVID R&D to test promising therapeutic candidates
faster than any single company could do operating alone. Members
are investigating marketed and late-stage therapies indicated for
other disease states, which, based on their mechanisms of action
may have a potential treatment effect in COVID-19 patients. The
group is employing adaptive platform trial methodologies that
enable the ability to test multiple therapies simultaneously and
modify protocols in real-time based on outcomes observed.
In addition to designing and sponsoring several platform trials,
the COVID R&D Alliance is:
- Evaluating more than 1,900 preclinical candidates against
active controls to uncover which hold the greatest promise for
COVID-19.
- Reviewing promising early-stage candidates that may show
potential efficacy against COVID-19, and connecting them with
potential funders from venture capital or pharmaceutical developers
to enable rapid advancement.
- Working with TransCelerate's DataCelerate® platform
to enable real-time data sharing and real-world evidence to inform
ongoing and future studies in COVID-19, so research communities
benefit from learnings and avoid duplication.
- Operating as an interlocutor with governments, regulators, and
non-governmental organizations to share insights and engage in
other platform trials.
About the I-SPY COVID Trial
The I-SPY COVID Trial
(Investigation of Serial Studies to Predict Your COVID Therapeutic
Response with Biomarker Integration and Adaptive Learning) is an
adaptive platform trial designed to increase trial efficiency by
minimizing the number of participants and time required to evaluate
experimental and/or repurposed drugs. The focus of the trial is to
improve outcomes for severely-ill COVID-19 patients—those who
require at least 6L of high-flow oxygen either by mask or nasal
cannula, known as level 5 on the World Health Organization (WHO)
COVID scale, an 8 point ordinal scale of clinical severity status.
The primary endpoint of I-SPY COVID is time to achieve level 4 (or
less) for at least 48 hours on the WHO COVID scale. Key secondary
endpoints include duration of time on ventilator and mortality.
The I-SPY COVID Trial is sponsored and managed by Quantum Leap
Healthcare Collaborative. For more information, visit
www.quantumleaphealth.org or www.ispytrials.org.
About the COVID R&D Alliance
Organized in
March 2020, the COVID R&D
Alliance is operating unconstrained by past models of development
and is accelerating study candidates without regard to company
affiliation. Members are sharing clinical trial data and real-world
evidence, as well as crowd-sourcing early stage candidates to
identify mechanisms and treatments that may be effective against
COVID-19. Initial efforts by the group focus on advancing well
understood therapies and late-stage investigational medicines for
severely ill patients who need options. Future activities will
expand to testing re-purposed molecules, early stage candidates,
and therapeutic drug combinations.
Additional information on the COVID R&D Alliance is
available at www.CovidRDAlliance.com.
About Cenicriviroc (CVC)
CVC is an oral, once-daily,
potent immunomodulator that blocks two chemokine receptors, CCR2
and CCR5, which are intricately involved in the inflammatory and
fibrogenic pathways in nonalcoholic steatohepatitis (NASH) known to
cause liver damage including cirrhosis, liver cancer, or liver
failure. These pathways have also been shown to be closely involved
with the respiratory sequelae of COVID-19 and of related viral
infections. Because of CVC's unique mechanisms of action, the drug
has been viewed as having a potential role in the treatment of
COVID-19 patients, in addition to its potential in the management
liver fibrosis due to NASH, including as a part of
combination-treatment strategies. CVC has been studied in both NASH
patients and in HIV+ patients, and is in Phase 3 development for
NASH. CVC has been granted Fast Track status in adults with liver
fibrosis due to NASH, the population at highest risk of progression
to cirrhosis.
About Otezla®
(apremilast)
OTEZLA® (apremilast) is an oral
small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for
cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in
increased intracellular cAMP levels, which is thought to indirectly
modulate the production of inflammatory mediators. The specific
mechanism(s) by which Otezla exerts its therapeutic action in
patients is not well defined.
Otezla is currently approved for use in more than 45 countries
as an oral treatment for inflammatory diseases including psoriasis,
psoriatic arthritis and Behçet's disease. By inhibiting PDE4,
Otezla is thought to modulate the production of inflammatory
cytokines and other mediators, which may prove helpful in
inhibiting the inflammatory response associated with the signs,
symptoms and pulmonary involvements observed in some COVID-19
patients. Amgen plans to collaborate with platform trials to
investigate Otezla's ability to prevent clinical deterioration in
patients with COVID-19.
Otezla® (apremilast) U.S.
INDICATIONS
Otezla® (apremilast) is indicated for
the treatment of adult patients with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic
therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT SAFETY
INFORMATION
Contraindications
- Otezla® (apremilast) is contraindicated in patients
with a known hypersensitivity to apremilast or to any of the
excipients in the formulation
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts, or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Psoriasis: Treatment with Otezla is associated with an increase
in depression. During clinical trials, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the phase 3 clinical trial, 1%
(1/104) reported depression or depressed mood compared to 1%
(1/103) treated with placebo. No instances of suicidal ideation or
behavior were reported in patients treated with Otezla or treated
with placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Psoriasis: During clinical trials, body weight loss of 5-10%
occurred in 12% (96/784) of patients treated with Otezla and in 5%
(19/382) of patients treated with placebo. Body weight loss of ≥10%
occurred in 2% (16/784) of patients treated with Otezla compared to
1% (3/382) of patients treated with placebo
- Psoriatic Arthritis: During clinical trials, body weight loss
of 5-10% was reported in 10% (49/497) of patients taking Otezla and
in 3.3% (16/495) of patients taking placebo
- Behçet's Disease: During the phase 3 clinical trial, body
weight loss of >5% was reported in 4.9% (5/103) of patients
taking Otezla and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy
may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin,
phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
- Psoriasis: Adverse reactions reported in ≥5% of patients were
(Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper
respiratory tract infection (9, 6), tension headache (8, 4), and
headache (6, 4)
- Psoriatic Arthritis: Adverse reactions reported in at least 2%
of patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 16
weeks (after the initial 5-day titration), were (Otezla%,
placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9,
2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2,
0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0,
0.2)
- Behçet's Disease: Adverse reactions reported in at least ≥5% of
patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 12
weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea
(19.2, 10.7); headache (14.4, 10.7); upper respiratory tract
infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting
(8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract
infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women.
Advise pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or visiting
https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition
- Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min) for details, see Dosage and Administration, Section 2, in
the Full Prescribing Information
Please click here for Otezla® Full Prescribing
Information.
About Firazyr® (icatibant
injection)
FIRAZYR® (icatibant injection) is a
bradykinin B2 receptor antagonist indicated for the treatment of
acute attacks of hereditary angioedema (HAE) in adults 18 years of
age and older. Indication may vary by country. It is administered
by subcutaneous injection. It is thought that icatibant may
ameliorate bradykinin-driven pulmonary edema by blocking the
bradykinin-2 receptors.
Firazyr® (icatibant injection) IMPORTANT SAFETY
INFORMATION
Laryngeal attacks can become life threatening. If you have an
HAE attack of the throat (laryngeal attack), inject icatibant
injection and then go to the nearest hospital emergency room right
away.
The most common side effects of icatibant injection include:
- redness, bruising, swelling, warmth, burning, itching,
irritation, hives, numbness, pressure, or pain at the injection
site
- fever
- too much of an enzyme called transaminase in your blood
- dizziness
- nausea
- headache
- rash
These are not all of the possible side effects of icatibant
injection. Tell your healthcare provider if you have any side
effect that bothers you or that does not go away. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Tell your healthcare provider if you have any other medical
conditions, if you are breastfeeding or plan to breastfeed, or if
you are pregnant or planning to become pregnant. Icatibant
injection has not been evaluated in pregnant or nursing women. You
and your healthcare provider will decide if icatibant injection is
right for you.
If your symptoms continue or come back, you may repeat your
icatibant injection at least 6 hours apart. Do not use more than 3
doses of icatibant injection in a 24-hour period. Tiredness,
drowsiness, and dizziness have been reported following the use of
icatibant injection. If this occurs, do not drive a car, use
machinery, or do anything that needs you to be alert.
Please see the full Prescribing Information.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health, and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing, and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be the world's largest
independent biotechnology company, has reached millions of patients
around the world and is developing a pipeline of medicines with
breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, including Adaptive
Biotechnologies (including statements regarding such
collaboration's, or our own, ability to discover and develop
fully-human neutralizing antibodies targeting SARS-CoV-2 to
potentially prevent or treat COVID-19), or the Otezla® (apremilast)
acquisition, including anticipated Otezla sales growth and the
timing of non-GAAP EPS accretion, as well as estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes, effects of
pandemics or other widespread health problems such as the ongoing
COVID-19 pandemic on Amgen's business, outcomes, progress, or
effects relating to studies of Otezla as a potential treatment for
COVID-19, and other such estimates and
results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including its most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates. Further, any scientific information discussed in this
news release relating to new indications for Amgen's products is
preliminary and investigative and is not part of the labeling
approved by the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
About Takeda Pharmaceutical Company Limited
Takeda
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global,
values-based, R&D-driven biopharmaceutical leader headquartered
in Japan, committed to bringing
better health and a brighter future to patients by translating
science into highly-innovative medicines. Takeda focuses its
R&D efforts on four therapeutic areas: Oncology, Rare Diseases,
Neuroscience, and Gastroenterology (GI). We also make targeted
R&D investments in Plasma-Derived Therapies and Vaccines. We
are focusing on developing highly innovative medicines that
contribute to making a difference in people's lives by advancing
the frontier of new treatment options and leveraging our enhanced
collaborative R&D engine and capabilities to create a robust,
modality-diverse pipeline. Our employees are committed to improving
quality of life for patients and to working with our partners in
health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
Takeda Forward-Looking Statements
This press release
and any materials distributed in connection with this press release
may contain forward-looking statements, beliefs or opinions
regarding Takeda's future business, future position and results of
operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often
include words such as "targets", "plans", "believes", "hopes",
"continues", "expects", "aims", "intends", "ensures", "will",
"may", "should", "would", "could" "anticipates", "estimates",
"projects" or similar expressions or the negative thereof. These
forward-looking statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those expressed or implied
by the forward-looking statements: the economic circumstances
surrounding Takeda's global business, including general economic
conditions in Japan and
the United States; competitive
pressures and developments; changes to applicable laws and
regulations; the success of or failure of product development
programs; decisions of regulatory authorities and the timing
thereof; fluctuations in interest and currency exchange rates;
claims or concerns regarding the safety or efficacy of marketed
products or product candidates; the impact of health crises, like
the novel coronavirus pandemic, on Takeda and its customers and
suppliers, including foreign governments in countries in which
Takeda operates, or on other facets of its business; the timing and
impact of post-merger integration efforts with acquired companies;
the ability to divest assets that are not core to Takeda's
operations and the timing of any such divestment(s); and other
factors identified in Takeda's most recent Annual Report on Form
20-F and Takeda's other reports filed with the U.S. Securities and
Exchange Commission, available on Takeda's website
at: https://www.takeda.com/investors/reports/sec-filings/ or
at www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
other forward-looking statements it may make, except as required by
law or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda's future results.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501(C)(3) charitable
organization established in 2005 as a collaboration between medical
researchers at University of California, San
Francisco and Silicon Valley entrepreneurs. Our mission is to
integrate high-impact research with clinical processes and systems
technology, resulting in improved data management and information
systems, greater access to clinical trial matching and sponsorship,
and greater benefit to providers, patients, and researchers. Our
goal is to improve and save lives. Quantum Leap provides
operational, financial, and regulatory oversight to the I-SPY
Trials. For more information,
visit www.QuantumLeapHealth.org.
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